New FDA Approval Path for 'Breakthrough' Devices

WASHINGTON -- The FDA has announced a new initiative to speed "pioneering" medical devices to the market, and its first test will be a novel upper-extremity prosthetic that is controlled by the brain.

The initiative, dubbed the Innovation Pathway, is designed to encourage cutting-edge technologies among medical device manufacturers, according to a press release sent Tuesday morning from the FDA's Center for Devices and Radiological Health (CDRH).

"Each year, millions of American patients benefit from innovative medical devices that reduce suffering and treat previously untreatable conditions," said CDRH Director Jeffrey Shuren, MD, JD, in a prepared statement. "CDRH's Innovation Initiative will help accelerate the development of and patient access to innovative medical devices, which often fulfill unmet public health needs."

On a Tuesday afternoon call with reporters, Shuren said he expects just one or two devices to be approved through the new pathway each year.

The first device up for review under the new pathway comes from the Defense Advanced Research Projects Agency (DARPA), the research arm of the Department of Defense.

The brain-controlled prosthetic is designed to restore near-natural arm, hand, and finger function to patients suffering from spinal cord injury, stroke, or amputation. An implanted microchip on the surface of the brain records neuronal activity, decodes the signals, and activates motor neurons that control the prosthesis.

The first chip will be implanted in a patient within six months, Geoffrey Ling, MD, PhD, program manager at DARPA, told reporters.

In order for a device to be considered for approval through the Innovation Pathway, it would have to reflect "truly pioneering technologies with the potential of revolutionizing patient care or healthcare delivery," according to the FDA.

If a company (or government agency) applies for approval through the Innovation Pathway process, it would receive a memo from CDRH with a proposed road map to device development, and the device might qualify for a "flexible" clinical trial protocol.

The devices would be reviewed by a new oversight body, the Center Science Council, that is currently being developed within CDRH.

The FDA could conduct premarket reviews of products in the Innovation Pathway within 150 days, nearly half the time it currently takes the FDA to review most premarket approval applications, according to the release.

CDRH already has an accelerated approval process for new devices, as well as a pathway for devices that are similar to ones already on the market. But Shuren said the Innovation Pathway is a "radically different kind of approach."

Generally, device makers contact the FDA when they're near the end of their development process. Under the Innovation Pathway, they would work with FDA reviewers very early on in the process, such as when the company is developing the device prototype.

CDRH is soliciting public comment on the Innovation Initiative and will host a public meeting on the issue on March 15.

Tuesday's announcement comes as the agency reviews another fast-track approval process, the 510(k) procedure, which was set up to streamline the process of clearing low- to moderate-risk medical devices and in vitro diagnostics for marketing.

Instead of requiring full clinical safety and efficacy data, as is the case for high-risk devices and all drugs, companies can seek faster FDA clearance by documenting that a product is similar to an existing approved device and poses no new safety concerns.

The 510(k) process has come under fire both from industry and from consumer advocates, many healthcare professionals, and some politicians, though on different grounds. Industry has complained that the process is administered inconsistently and with vague standards, such that manufacturers do not know what is likely to be required for a new product.

But well-publicized safety problems associated with some products approved under the 510(k) scheme have prompted criticism that the agency is too cozy with industry and fails to demand adequate clinical data.

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